The purpose of this study is to evaluate the effect of food on the pharmacokinetics of a single oral dose of fezolinetant under fasted and fed conditions in healthy female participants. The study will also evaluate the safety and tolerability of a single oral dose of fezolinetant under fasted and fed conditions in healthy female participants.
Each participant will participate in 2 treatment periods separated by a washout of at least 5 days between investigational product (IP) administration in each period. Participants will be admitted to the clinical unit on day -1 of period 1 and will be in clinical unit for periods 1 and 2. On day 1 of each period, participants will receive fezolinetant followed by a 72-hour blood sampling period. The study will be completed with an end-of-study visit (ESV) which will take place 5 to 9 days after the 72-hour blood sampling period in period 2 or at the time of early discontinuation from the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
16
Oral
Parexel
Baltimore, Maryland, United States
Pharmacokinetics (PK) of fezolinetant in plasma: Area under the concentration-time Curve (AUC) from the time of dosing extrapolated to time infinity (AUCinf)
AUCinf will be recorded from the PK plasma samples collected.
Time frame: up to Day 4 in each study period.
Pharmacokinetics (PK) of fezolinetant in plasma: Area under the concentration-time curve (AUC) from the time of dosing to the last measurable concentration (AUClast)
AUClast will be recorded from the PK plasma samples collected.
Time frame: up to Day 4 in each study period.
Pharmacokinetics (PK) of fezolinetant in plasma: Maximum concentration (Cmax)
Cmax will be recorded from the PK plasma samples collected.
Time frame: up to Day 4 in each study period.
Pharmacokinetics (PK) of fezolinetant in plasma: Time of maximum concentration (Tmax)
Tmax will be recorded from the PK plasma samples collected.
Time frame: up to Day 4 in each study period.
Number of participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant administered an IP, whether or not considered related to the IP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP. This includes events related to the comparator and events related to the (study) procedures.
Time frame: up to Day 18
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant laboratory values.
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Time frame: up to Day 18
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Number of participants with potentially clinically significant vital sign values.
Time frame: up to Day 18
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with potentially clinically significant electrocardiogram (ECG) values.
Time frame: up to Day 18